1. Field of the Invention
The present invention relates to a vaginal stimulator and a device for the treatment of female urinary incontinence by the way of electrical stimulation applied to the pelvic floor musculature and surrounding structures.
2. Description of the Prior Art
Female urinary incontinence is a condition with severe economic and psychosocial impact. There are several types of urinary incontinence but all are characterized by an inability to restrain urinary voiding. The three most frequent types of urinary incontinence are the stress incontinence, characterized by the involuntary loss of urine from the urethra during physical exertion, the urge incontinence or involuntary loss of urine associated with an abrupt and strong desire to void, and the mixed urinary incontinence which results from both urge incontinence and stress incontinence.
Various methods have been propesed for improving the strength and tone of the pelvic floor muscle group. In 1948, Arnold Kegel described pelvic floor exercises as a treatment option in stress incontinence and invented a set of exercises to strengthen and support the pelvic floor. The purpose of the Kegel exercises is to increase volume and to develop stronger reflex contractions following quick rise in intra-abdominal pressure. Many women find these Kegel exercises difficult and uncomfortable to perform and the major obstacle to success with Kegel exercises is the tendency among women to give up or forget how to correctly do the exercises.
Electrical stimulation of the pelvic floor is an effective therapy both for stress incontinence and urge incontinence. Electrical stimulation of the pelvic floor automates Kegel exercises through the use of direct electrical stimulation of the vagina and bladder muscle. Electrical stimulation of the pelvic floor to treat stress incontinence and urge incontinence was first studied in the early 1960""s and clinical studies from the 70""s through 90""s have reaffirmed its effectiveness.
With the first electrical stimulation methods used to treat female urinary incontinence, women had to go in a medical setting to undergo electrical stimulation session of their pelvic floor muscle. Later electrical stimulators for home treatment appeared. These devices are usually in two parts: an inside vagina part which is a vaginal plug with electrodes intended to be in contact with the vagina wall and an outside vagina part which can be the pulse generator and a power supply or a power supply only if the pulse generator is inside the vaginal plug. Such devices are not convenient because of the cable(s) between the inside vagina part and the outside vagina part. Moreover, hygiene problems are encountered when the vaginal plug has not been completely cleaned before its insertion in the vagina.
Other devices are used with a special condom which must be disposed of and changed after each use.
Said devices of the prior art are not well accepted by the women because they are exacting and difficult to use. With some devices the insertion and the extraction of the plug are not easy, the presence of cables and/or cumbersome equipment is not comfortable, the plugs are difficult to clean, the user must have batteries in advance, and in the case of devices used with condoms the user must have condoms in advance. There is then a need for a pelvic floor muscle electrical stimulation device effective, convenient to use and easy to insert, extract and clean.
The present invention is directed to a vaginal stimulator with a body adapted to be inserted in women""s vagina to electrically stimulate the pelvic floor musculature and surrounding structures, comprising a battery as power supply, means for applying preprogrammed instructions concerning the current frequency adapted to the type of incontinence to be treated and the treatment duration.
Advantageously, said means for applying preprogrammed instructions comprise a microcontroller to select the pulse frequency and the working time given by an outer electronic control system. In a preferred embodiment of the invention, said electronic control system is located in a case comprising a housing for said stimulator, when not in use.
Preferably, said vaginal stimulator body comprises on its surface, at least two sets of conductors, a first set being used as electrodes to transmit electrical pulses to the pelvic floor musculature, and a second set, which, jointly with the first one, is able to transmit the instructions of the operator to the vaginal stimulator microcontroller.
Said vaginal stimulator is advantageously watertight.
It is convenient that an eyelet be provided at one end of the vaginal stimulator body, with a guide to thread a string into the eyelet.
The invention is also directed to a device for the treatment of female urinary incontinence by electrical stimulation applied to the pelvic floor musculature and surrounding structures, comprising a vaginal stimulator as above defined and a carrying and control case, without cable linking one to the other.
In a preferred embodiment, the carrying and control case comprises a housing for said vaginal stimulator, a transformer with charge circuitry to charge the vaginal stimulator battery, an electronic control system to transmit the instructions given by the operator.
Said housing is advantageously provided with metal contacts arranged to be in contact with the conductors of the vaginal stimulator when put into the housing.
It further comprises a wedge adapted to go into the vaginal stimulator eyelet and intended to secure the position of the vaginal stimulator in the housing so that the conductors of the vaginal stimulator be always in contact with the corresponding metal contacts of the housing.
The above instructions are given by the operator to the vaginal stimulator microcontroller through control knobs.
The programmable vaginal stimulator of the present invention is very convenient and easy to use. Between each use the rechargeable battery of the vaginal stimulator is recharging when the vaginal stimulator is in its housing and the cover of the carrying and control case is closed. Before each use the user has only to select the type of incontinence and program the use time. Usually, this programming is done once and for all before the first use. After having thread a piece of string through the eyelet of the vaginal stimulator with the help of the guide string, the user can lubricate the vaginal stimulator to make easier its insertion in the vagina. Then the vaginal stimulator is inserted into the vagina like a tampon, just so it disappears into the vaginal opening. When the use time is passed, the device user takes out the vaginal stimulator from the vagina, cuts the string, throws it away, cleans the vaginal stimulator with mild soap or alcohol, or other disinfectants, wipes it, places it back in its resting nest and closes the cover of the carrying and control case. The battery will recharge automatically.